Allogeneic Hematopoietic Cell TransplantPhase 2NCT01903928
A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant
A Phase 2 study testing ASP0113 in people with Allogeneic Hematopoietic Cell Transplant, run by Astellas Pharma Inc at 2 sites in Japan.
Trial summary
This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Cell Transplant
- What is being tested?
- ASP0113
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesJapan
- Study dates
- 20 Jun 2013to 19 Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is planned to undergo either of the following:
- Sibling Donor Transplant - 7/8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DRß1 match utilizing low or high resolution typing.
- Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.
- Subject has one of the following underlying diseases: Acute myeloid leukemia (AML) /Acute lymphoblastic leukemia (ALL) / Acute undifferentiated leukemia (AUL) /Acute biphenotypic leukemia / Chronic myelogenous leukemia (CML) / Chronic lymphocytic leukemia (CLL) / myelodysplastic syndrome(s) (MDS)
- Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders
Who cannot join
- Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant
- Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins
- Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3
- Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
- Subject has received any of the following substances or treatments:
- T-cell depletion of donor cell product.
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- Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial.
- Administration of a CMV vaccine, including any prior exposure to ASP0113.
- Subject has received an allogeneic stem cell transplant within one year prior to transplant
- Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy
- Subject has an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will interfere with protocol requirements.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Open Phase 2 Trial to Evaluate Safety of a Therapeutic Vaccine, ASP0113, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.
- Conditions
- Allogeneic Hematopoietic Cell Transplant
- Being tested
- ASP0113
- Keywords
- cytomegalovirus, HCT, DNA vaccine, transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP0113Biological
injection
| Study group | Role | What they receive |
|---|---|---|
| ASP0113 group | Experimental | Participants receive 1 mL of ASP0113 intramuscularly 5 times, on days -14 to -3, 14 to 40, 60 ± 5, 90 ± 10, and 180 ± 10, counting from the transplantation (stem cell transfusion) day (day 0) Receives: Biological: ASP0113 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests
Measured: for 365 days after HCT
Secondary outcomes (5)
Local reactogenicity
protocol-specified reactogenicity scale
Measured: for 14 days following each injection
Incidence of CMV viremia
CMV plasma viral load ≥ 1000 copies
Measured: for 365 days after HCT
CMV-specified antiviral therapy
CMV-specific AVT(Anti-virus therapy) initiated for a CMV plasma viral load ≥ 1000 copies
Measured: for 365 days after HCT
Incidence of cytomegalovirus end-organ disease (CMV EOD)
CMV pneumonia, CMV gastroenteritis, CMV hepatitis, et al
Measured: for 365 days after HCT
Maximum grade of Graft Versus Host Disease (GVHD)
Measured: for 365 days after HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study start20 Jun 2013
- Primary completion19 Jan 2015
- Study completion19 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Hematopoietic Cell TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903928
- Sponsor's protocol ID
- 0113-CL-1003
- Status last verified
- Oct 2024
- First submitted
- 1 Jul 2013
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Mori T, Kanda Y, Takenaka K, Okamoto S, Kato J, Kanda J, Yoshimoto G, Gondo H, Doi S, Inaba M, Kodera Y. Safety of ASP0113, a cytomegalovirus DNA vaccine, in recipients undergoing allogeneic hematopoietic cell transplantation: an open-label phase 2 trial. Int J Hematol. 2017 Feb;105(2):206-212. doi: 10.1007/s12185-016-2110-3. Epub 2016 Oct 28.
PubMed 27796740
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase 2 Trial to Evaluate Safety of a Therapeutic Vaccine, ASP0113, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
- ClinicalTrials.gov ID
- NCT01903928
- Acronym / sponsor ID
- 0113-CL-1003
- Conditions
- Allogeneic Hematopoietic Cell Transplant
- Keywords
- cytomegalovirus, HCT, DNA vaccine, transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2013 (actual)
- Primary completion
- 19 Jan 2015 (actual)
- Study completion
- 19 Jan 2015 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP0113 group | Experimental | Biological: ASP0113Participants receive 1 mL of ASP0113 intramuscularly 5 times, on days -14 to -3, 14 to 40, 60 ± 5, 90 ± 10, and 180 ± 10, counting from the transplantation (stem cell transfusion) day (day 0) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is planned to undergo either of the following:
- Subject has one of the following underlying diseases: Acute myeloid leukemia (AML) /Acute lymphoblastic leukemia (ALL) / Acute undifferentiated leukemia (AUL) /Acute biphenotypic leukemia / Chronic myelogenous leukemia (CML) / Chronic lymphocytic leukemia (CLL) / myelodysplastic syndrome(s) (MDS)
- Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders
Key exclusion criteria (11 listed)
- Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant
- Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins
- Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3
- Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
- Subject has received any of the following substances or treatments:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP0113injection | Biological | ASP0113 group |
Primary outcome
Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests
Time frame: for 365 days after HCT
5 secondary outcomes
Local reactogenicity
Time frame: for 14 days following each injection
Incidence of CMV viremia
Time frame: for 365 days after HCT
CMV-specified antiviral therapy
Time frame: for 365 days after HCT
Incidence of cytomegalovirus end-organ disease (CMV EOD)
Time frame: for 365 days after HCT
Maximum grade of Graft Versus Host Disease (GVHD)
Time frame: for 365 days after HCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Derived from this study: PubMed 27796740Mori T, Kanda Y, Takenaka K, Okamoto S, Kato J, Kanda J, Yoshimoto G, Gondo H, Doi S, Inaba M, Kodera Y. Safety of ASP0113, a cytomegalovirus DNA vaccine, in recipients undergoing allogeneic hematopoietic cell transplantation: an open-label phase 2 trial. Int J Hematol. 2017 Feb;105(2):206-212. doi: 10.1007/s12185-016-2110-3. Epub 2016 Oct 28.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP0113 in people with Allogeneic Hematopoietic Cell Transplant, run by Astellas Pharma Inc at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests (time frame: for 365 days after HCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01903928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.